반응형 무균공정5 [PDA News] Cleanroom Process Risk Assessment Per Annex 1_20/03/01 https://pda.inloop.com/en/article/137266/cleanroom-process-risk-assessment-per-annex Cleanroom Process Risk Assessment Per Annex 1 In the final part of our five part series of Quality Risk Management per Annex 1, we explore the benefits of a Cleanroom Process Risk Assessment and how our Contamination Control Advisers can provide you with one. Process Risk Assessment: Why it’s importan pda.inloop.. 2020. 5. 8. [PDA News] Isolator Launch in South Korea(에이프로젠의 아이솔레이터(optima) 도입과 관련하여)_20/04/30 Isolator Launch in South Korea To date, very few filling and capping machines with isolator technology have been installed in South Korea, let alone in Asia. All of this will soon change. Both Oh-sung Na (Aprogen Biologics) and Peter Kim (Optima Korea) are certain of it because Aprogen pda.inloop.com [원문 위 링크 참조] * 의역/오역 있음. Isolator Launch in South Korea Optima Pharma GmbH / April 30 To date, v.. 2020. 5. 7. EU GMP Annex 1과 FFS(Form-Fill-Seal) / 수액제 제조공정 8.97 Form-Fill-Seal (FFS) units include blow moulding from thermoplastic granulate and thermoforming from thermoplastic film, typically known as Blow-Fill-Seal (BFS) and Vertical-Form- Fill-Seal (VFFS), respectively. VFFS process is an automated filling process, typically for terminally sterilized products, that may utilize a single or dual web system which constructs the primary container out o.. 2020. 3. 24. EU GMP Annex 1과 BFS(Blow-Fill-Seal) Equipment(Shuttle Type / Rotary Type) 8.102 Blow-Fill-Seal (BFS) units are purpose built machines in which, in one continuous operation, containers are formed from a thermoplastic granulate, filled and then sealed by one automatic machine. Air that makes contact with critical surfaces of the container during extrusion, formation or sealing of the moulded container should undergo appropriate filtration. BFS (Blow-Fill-Seal) 장치는 하나의 연.. 2020. 3. 24. 무균의약품 제조 공정 관련 가이드라인(1) EU GMP Annex 1 (2020) http://academy.gmp-compliance.org/guidemgr/files/2020_ANNEX1PS_STERILE_MEDICINAL_PRODUCTS_EN.PDF 불러오는 중입니다... 2020년 개정된 [EU GMP EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products (Draft)(2020)] 첨부합니다. 위 링크를 참고해주세요. 2020. 3. 4. 이전 1 다음 반응형
